Nebulizers Open Meeting - January 28, 2020 - JA DME

DR. ROBERT HOOVER

It's 11:30. Good morning and welcome to everybody that's here and on the phone. I'm Dr. Robert Hoover. I'm the Jurisdiction C DME MAC Medical Director, and the Medical Director responsible for the proposed Nebulizer LCD. I work with my colleagues at the front table here, and we all work collaboratively, and we are here to solicit comments on the proposed Nebulizer LCD.

We are going to be recording the meeting today, and we'll have the recording and transcript posted on the DME MAC websites in the future, after the meeting. Uh signing in today you are giving your consent to the use of your recorded image and voice, and any comments. Please be mindful of sharing any personal health information in your comments. We also ask that any comments made today also be submitted in writing to NEBLCDComments@cgsadmin.com. Again, that's NEBLCDComments@cgsadmin.com. The comment period will close at 5:00 p.m. eastern standard time on Monday, February the 10th. Details for submitting comments are also available on the Noridian and CGS websites.

We have commenters in person here in Dallas, um only registered commenters will be allowed to comment at today's meeting, but anyone can submit written comments to the address I mentioned a moment ago. For those commenting we have two hours for this meeting. For those in the room we'll have yellow and red signs warning when your time is almost up. For those on the phone, we ask that you mute your lines, do not hold them when you are speaking. Hold often gives us music in the background and it interferes with the call. Speakers should be prepared to present their comments immediately when called upon, and you'll hear the Moderator's voice when you have one minute remaining.

Now I'll introduce the DME MAC Medical Directors. Dr. Smitha Ballyamanda is the Jurisdiction A Medical Director at Noridian Healthcare Solutions. Jurisdiction A is comprised of eleven northeastern states and the District of Columbia. She is a family physician with a specialty training in sports medicine and has been a DME MAC Medical Director for one year. Dr. Stacy Brennan is the Jurisdiction B Medical Director at CGS Administrators. Jurisdiction B comprises seven midwestern states. She is a family physician and has been a DME Medical Director for thirteen years. Dr. Peter Gurk is the Jurisdiction D Medical Director at Noridian. Jurisdiction D is comprised of seventeen western states and three U.S. territories. He's an Emergency Room physician by training and has been a DME Medical Director for seven years. And as I mentioned, I'm Dr. Robert Hoover, I'm the Jurisdiction C Medical Director. Jurisdiction C encompasses fifteen states and the territories of Puerto Rico and the U.S. Virgin Islands. I'm an internist by training and I've been a DME Medical Director for more years than I like to admit, over two decades.

The proposed LCD we are here to comment on today provides coverage for revefenacin, brand name Yupelri®, which is manufactured by Mylan. revefenacin is a lung specific long acting muscarinic agent or LAMA, administered as an inhalation solution, and indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease or COPD. The recommended dose of revefenacin inhalation solution is one 175 microgram unit dose vile administered once daily via a standard nebulizer compressor. revefenacin was approved by the Food and Drug Administration on November 9, 2018 and is assigned HCPCS code J7677. The proposed LCD will add revefenacin coverage language under criterion A as a maintenance medication for the treatment of patients with COPD. In addition, since revefenacin is a long acting muscarinic agent, the proposed LCD stipulates that concurrent use of long acting and short acting muscarinic antagonists such as Ipratropium will be denied as not reasonable and necessary. The Medical Directors will now hear comments from the public.

JODY WHITTEN

Thank you, Dr. Hoover. We have one comment and that commenter is here in person. Zuma Schlossberg, if you can please come up? Being you are the only commenter; you have an hour and 40 minutes.

ZUMA SCHLOSSBERG

I don't think I will need the hour and 40 minutes. So, I have my comments here and I will submit them. Um so good morning, my name is Zuma Schlossberg, and I am a Director MSL for Mylan, and I will be speaking to the LCD um proposed wording for revefenacin. As mentioned previously, revefenacin Inhalation Solution is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease, and during this talk I'll just abridge it to COPD and is nebulized via standard jet nebulizer.

A point to consider um during this talk is in cases where a long acting um inhibitory antagonist, which is revefenacin, is prescribed to a patient that is on a short acting muscarinic antagonist we recommend the preferential approval of revefenacin as a maintenance treatment of COPD based on the recommendations of um what we call the Gold Report, which helps clinicians treat COPD. And we specifically request that the proposed LCD language be updated to reflect this position.

Um as you know, or may not know, COPD is a common preventable and treatable disease, and is characterized by persistent respiratory symptoms, air flow limitations due to um alveolar abnormalities. And this is caused usually by noxious stimuli or particles or gasses. In the majority of the cases this is due to smoking. COPD is the fourth leading cause of death in the United States, affecting over 15 million people, and this was uh back in 2017. And depending on what journal you read, it's either the third or the fourth leading cause of death. Um COPD patients in the United States have frequent ER visits, have high hospitalization rates if they are not properly maintained, frequent readmissions, and these are major drivers for healthcare costs.

There is also a large selection of agents that are used to treat COPD. It is a progressive disease, as we mentioned, and many of these elderly patients will eventually need nebulized drugs due to the worsening of lung function. And this is a very vulnerable population. The GOLD, or the Global Initiative for the Chronic Obstructive Lung Disease report, um provides guidance for the treatment of COPD. This report recommends the use of long acting bronchodilators for the maintenance treatment of COPD, and revefenacin falls into this category as a long acting muscarinic beta agonist, muscarinic antagonist. The GOLD report states that the use of short acting muscarinic antagonists alone does not improve lung function.

Um the clinical development of revefenacin was quite extensive, and it included two 12-week randomized, double blind, placebo controlled, multiple dose parallel group confirmatory trials in which subjects that had moderate to very severe COPD were evaluated, um randomized and evaluated, with once daily revefenacin's effects on lung function. So, the subjects enrolled in these particular COPD studies had to be over 40 years of age; they had to have a clinical diagnosis of COPD, have a history of smoking greater than or equal to ten pack years, and have moderate to severe COPD. These trials, trials I and II, enrolled uh 1,229 patients, of which 395 received the 175-microgram dose that was approved by the FDA, via standard jet nebulizer. The rescue medication was Albuterol, it's a short acting beta agonist. And it was given PRN as needed. The primary end point was change from baseline in trough, or predose in their uh forced expiratory volume at one second at day 85. So, this was a 12-week study. So, in both trials revefenacin at 175 micrograms demonstrated significant improvement in the lung function for the mean change from baseline in trough or predose FEV1 of about 146 in trial I and 147 mils in trial II compared to placebo, and this was statistically significant.

Part of the confirmatory trials included quality of life analysis called the St. George Respiratory Questionnaire. And this particular questionnaire is done in clinical studies, primarily, not used out in the public. Um and of the patients that responded to this questionnaire that was in the trial, 49% of those in revefenacin's treatment arm um on day 85, compared to 34% in the placebo, had a four-point increase in their quality of life scale. So, when you have four points or more it becomes statistically significant. And looking at the side effects of revefenacin in the confirmatory trials, the anticholinergic side effects such as constipation, dry mouth and dysuria, which is what you are looking for in these particular agents, um was less than 1%.

So, at this time I thank you for your time and for listening, and I yield back all the time.

JODY WHITTEN

Thank you. Dr. Hoover?

DR. ROBERT HOOVER

Well thank you for your comments, and we appreciate the brevity. Um so I'll discuss the next steps as part of the reconsideration process. First, the DME MACs will take into account all the comments that were submitted today and any other comments that are submitted in writing to us during the open comment period. As I mentioned, for those of you that may be listening on the phone, NEBLCDComments@cgsadmin.com. And the comment period closes at 5:00 o'clock eastern time on Monday, February the 10th. Once the comment period closes, we consider all comments and review them, make any additional changes, any research that needs to be done based on those comments, and then post the final LCD along with a response comments document. The DME MACs will post the final LCD on our websites and distribute links for that information by our list servs. The final LCD will take effect in a minimum of 45 days, following the posting of the final LCD. That concludes our open meeting today for the proposed nebulizer LCD. Thank you for your attendance, and this meeting is adjourned.